Clinical trial of the high intensity focused ultrasound (HIFU) system for prostate cancer treatment commences at Georgetown University Medical Center under an investigational device exemption approved Jan. 8. Baylor University and the University of California at San Francisco also will participate in the 120-patient trial, which will enroll those who already have been treated with radiation but have experienced a recurrence
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Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
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